Ironwood Pharmaceuticals, Inc. IRWD incurred first-quarter 2019 adjusted loss of 26 cents per share, wider than the Zacks Consensus estimate of a loss of 16 cents either because the year-ago loss of 25 cents.
Total revenues at the first district were $68.7 million, nearly even year at year because higher Linzess collaboration revenues were partially offset by lower (active pharmaceutical ingredient) API sales ought Japan-based Astellas. The peak queue either missed the Zacks Consensus estimate of $83.14 million.
On Apr 1, 2019, Ironwood completed its previously announced separation into two public entities.
Following the separation at April, Ironwood is focusing at commercial drugs and gastrointestinal (“GI”) pipeline development. The new entity, Cyclerion, will concentrate at developing the Soluble Guanylate Cyclase (sGC) pipeline because treating grave and orphan diseases.
From second district onward, Ironwood will interpret estate and commerce operations related ought sGC pipeline because discontinued operations.
Shares of Ironwood crashed 12.8% following the dismal salary performance. at fact, the stock has declined 0.8% accordingly far this year agianst the industry’s arise of 9%.
Quarter at Detail
As reported by companion Allergan plc AGN, Ironwood’s key marketed product — Linzess —generated net sales of $161.3 million at the United States, up 1.3% year at year. Ironwood and Allergan equally portion brand collaboration profits or losses because Linzess.
Ironwood's portion of net profits from sales of Linzess at the United States (included at collaborative revenues) was $64.3 million at the first quarter, up nearly 5.7% year at year. entire commercial favour at the reported district was $94.4 million.
Sales of linaclotide API added $2.6 million ought revenues including sales ought the company’s Japanese companion Astellas Pharma. The corporation either earned $1.8 million from linaclotide royalties, co-promotion and other revenues.
Per news provided by IQVIA, volume of prescribed Linzess capsules at the first district increased nearly 14% year at year. However, lower realization of net prices unfavorably impacted sales of the drug.
In January, Ironwood and Allergan settled a pending patent litigation with Mylan Pharmaceuticals MYL, the third settlement related ought Linzess. Per the settlement terms, Mylan will exist granted license ought launch generic translation of Linzess at February 2030 because 145 mcg and 290 mcg doses, and at August 2030 because 72 mcg dose.
During the reported quarter, selling and administrative (SG&A) expenses increased 8.8% ought $64.7 million chiefly owing ought separation costs, partially offset by diminish at sales and marketing programs and employee-related expenses.
Research and development (R&D) expenses were $54 million, up 47.9% from the year-earlier period, chiefly owing ought amplify at costs related ought early-stage pipeline candidates.
2019 Guidance
Ironwood maintained its guidance because entire revenues at the hill of $370-$390 million because 2019. Net favour expenses are anticipated ought exist nearly $35 million. The corporation provided its salary anticipate because 2019 including the impact of the commerce separation. The corporation expects adjusted EBITDA ought exist more than $65 million. It either expects net sales of Linzess ought alter by low-to-mid sole digit percent point.
The corporation expects ought alter advantageous at 2019 because the first time because its inception.
Pipeline Updates
Linzess is approved at the United States because the treatment of adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (“CIC”). Ironwood and Allergan are looking ought amplify Linzess’ label into additional symptoms and ripen the medicine because a non-opioid, pain-relieving deputy because IBS patients.
During the quarter, Ironwood and Allergan completed dosing at the phase IIIb program evaluating a 290-mcg dose of Linzess because multiple abdominal symptoms at addition ought pain including bloating and discomfort at adult patients with irritable bowel syndrome over with constipation (IBS-C). Top-line news from the learn is expected by mid-2019.
Linzess is marketed by Allergan because IBS-C at Europe and Canada beneath the brand call Constella.
The companies anticipate ought commence a phase IIb learn at can because evaluating MD-7246 (delayed liberate formulation of Linzess) ought treat abdominal pain associated with IBS with diarrhea.
The corporation is either developing an interesting candidate called IW-3718. It is currently enrolling patients at two coat phase III studies, evaluating IW-3718 because treating gastroesophageal reflux sickness (“GERD”). Results from both studies are expected at the second half of 2020.
Global Collaborations and Partnerships
Ironwood has a license council with Japan based, Astellas Pharma. Ironwood supplies linaclotide API ought Astellas Pharma because manufacturing and developing Linzess because sale at Japan. at China, Hong Kong and Macau, Ironwood has a marketing council with AstraZeneca AZN because Linzess.
In January, Linzess was granted marketing approval by Chinese regulatory authorities ought treat adults with IBS-C. Ironwood and AstraZeneca design ought launch the medicine at China at the second half of 2019.
Our Take
Ironwood reported dismal first-quarter results with sales and salary missing estimates. However, Linzess’ prospects emerge encouraging due ought strong appeal trends and the drug’s expansion ought new patient population and geographies.
The new Ironwood entity has high latent because it is expected ought exist a advantageous chance after the rip and its concentrate at the gastrointestinal product of commercial portfolio and pipeline appears impressive.
Moreover, the company’s $119 million money estate owing ought March-end, separation of sGC pipeline and a strong companion at Allergan bode well.
Ironwood Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Ironwood Pharmaceuticals, Inc. Price, Consensus and EPS amaze | Ironwood Pharmaceuticals, Inc. Quote
Zacks Rank
Ironwood currently carries a Zacks kind #2 (Buy). You can look the end list of today’s Zacks #1 kind (Strong Buy) stocks here.
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